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Medicine United States News

FDA Panel Backs First Rapid, Take Home HIV Test 94

Posted by samzenpus
from the privacy-of-your-own-home dept.
TheGift73 writes in with news about an over-the-counter HIV test getting the backing of a panel of FDA experts. "American consumers may soon be able to test themselves for the virus that causes AIDS in the privacy of their own homes, after a panel of experts on Tuesday recommended approval of the first rapid, over-the-counter HIV test. The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panelists said it could provide an important way to expand HIV testing. The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel."
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FDA Panel Backs First Rapid, Take Home HIV Test

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  • IV use and Bareback anal sex should go through the roof.
  • by MRe_nl (306212) on Wednesday May 16, 2012 @05:55PM (#40022213)

    Unsupervised false positives.

  • This has the potential to further the spread of HIV. Someone who might otherwise get tested by a professional may opt for this test and consider themselves negative and proceed to have unprotected sex.
    • by gatfirls (1315141)
      Yes, there we are. I love that kind of logic. I'm sure the net effect will be a further spread of HIV.
      • by zlives (2009072)

        for those who thought putting on a condom was a chore :) just wait till you have to swab and wait 20 minutes before "random sex"

    • by MrEricSir (398214)

      But then again, someone who wouldn't have gotten tested by a doctor (out of embarassment, or perhaps financial reasons) now might be likely to self-test.

      Only time will tell what impact this has.

      • I will admit that I could fall into the possible-self-test camp. I have no reason to believe that I have HIV, and there's no practical risk of me spreading it to anyone who wouldn't have already been exposed. If it's inexpensive, why not? It's like the automated blood pressure cuffs at every pharmacy. If it turned out Negative, I'd continue thinking there's very little chance I have it. If it turned out Positive, I'd go get a real test from a doctor.
        • by zlives (2009072)

          FTFY "I have no reason to believe that I have HIV (virgin), and there's no practical risk of me spreading it to anyone who wouldn't have already been exposed (hand)"

          sorry it was just right there...

    • by vistic (556838) on Wednesday May 16, 2012 @08:01PM (#40023389)

      If you go to a lot of clinics, this is the exact same test they will give you there (OraQuick).

      I've had this test done a few times and it always seems pretty brainless to do it. I don't think there's much risk of someone getting a false positive or false negative from something they did wrong. It's similar to a home pregnancy test I think... there's a thing that shows up whether its negative or positive, and if its positive then another thing would show up in addition to that.

      In terms of accuracy and all that, they say it's like 99% as effective as the old way where they drew blood and shipped it off to a lab for 2 weeks.

      Of course if someone did get a false positive, then they would probably go to a doctor for a more careful test.

      And of course if someone is really obsessive compulsive about it and worried they have a false negative, they can buy a bunch and test themselves daily if they really wanted to.

      The only effect I can see from this being made available is a LOT more people will know their status now. Or at least have a 99% clear indication.

      The only downside really is that they won't get to talk to a doctor. A doctor would inform them about the time "window" between time of infection and the time it would show up on a test. If there are false negatives, that's where it would be from: People mistakenly thinking they can test for HIV the day after they might have been infected.

  • In the clinical lab arena we have already had pregnancy-style HIV tests for years. This is nothing new. Good to see it come to the home, though. This will be much cheaper for people.
  • False positive - someone could get seriously beaten, even killed. After all, if you figure you're going to die anyway, why not take it out on the person who you thought gave it to you?

    False negative - you're going to spread it to others, plus delay getting treatment yourself.

    In both cases, you're still going to need to re-do the test if you're at all sane, so this is just a money grab by some drug co.

    • by Anonymous Coward

      False positive - someone could get seriously beaten, even killed. After all, if you figure you're going to die anyway, why not take it out on the person who you thought gave it to you?

      False negative - you're going to spread it to others, plus delay getting treatment yourself.

      In both cases, you're still going to need to re-do the test if you're at all sane, so this is just a money grab by some drug co.

      Design the test to error on the side of more false positives. Then the test result should have 'no result' or a 'negative' . This way the test can reliably exclude people who are true negatives from the rest who should get blood tests.

      If the manufacturer can do this. It may not be possible to design the test this way.

      • The test is only 93% accurate in home use when detecting people wiht HIV. In other words, it misses 7 out of every 100 cases ... people who will then go on to assume they've dodged the bullet, and can unknowingly give it to others.

        For something that is literally going to be involved in making life and death decisions, such a large error rate is unacceptable.

        • by Belial6 (794905) on Wednesday May 16, 2012 @06:32PM (#40022577)
          With a 20 minute outcome. I would require every new partner I have sex with to take the test. A cheek swab and 20 minutes of none penetrating fooling around is simply not that much to ask. For those that have lots of partners, a 93% error rate would pinpoint them pretty darn quick. For those that are monogamous, they are no worse off than before, and can still retest.

          I see this as more useful for testing those that you will be having sex with than for testing yourself. Keep in mind, by the time the test comes up, most people would have already decided to have sex with the other person. Not having the test at all would result in the exact same activity as having the test and getting a false negative. Now, if they could just get the same kind of test for herpes, we would be set to go.
        • by Anonymous Coward

          Detecting the virus in 93% of people who have it is not 93% accurate. You also need to factor in the true negatives and false positives, not just the true positives and false negatives. I couldn't see those rates in the linked article.

        • by Capt.DrumkenBum (1173011) on Wednesday May 16, 2012 @06:39PM (#40022659)

          For something that is literally going to be involved in making life and death decisions, such a large error rate is unacceptable.

          As compared to the error rate inherent in, "Well, I feel healthy."
          As someone who has had the experience of having my GF tell me she had just tested positive. Then having to go see the doctor, then the blood test, then wait for results. I had the first Dr. appointment of the day and the doctor was running late. I nearly lost my mind waiting.
          I think a test like this would have saved me a lot of stress.
          In case anyone cares, my test came back negative, and again 6 months later.
          This was almost 20 years ago and testing HIV+ was pretty much a death sentence back then.

          • False dichotomy. I think you'd agree that a third option - requiring that they make the test much more accurate - is a win/win for everyone.
          • HIV transfer. (Score:4, Informative)

            by queazocotal (915608) on Wednesday May 16, 2012 @07:51PM (#40023297)

            Your case raises the interesting issue of transmissibility.

            It's been found through studies of cases like yours that 'vanilla' couples sex, where the partners are otherwise healthy apart from one being HIV+ have well under a percent (.3% IIRC) rate per act of transmitting HIV.
            For anal, this rises to 30%.

            The reproductive system - in the absence of sores or other problems due to other diseases - is remarkably good at protecting itself from disease.

            • It's been found through studies of cases like yours that 'vanilla' couples sex, where the partners are otherwise healthy apart from one being HIV+ have well under a percent (.3% IIRC) rate per act of transmitting HIV.

              I can tell you that we were quite vigorous, and on more than one occasion I did see a hint of pink afterwords. On at least one occasion I know I was a bit rubbed raw.
              Honestly I was a bit surprised when the doctor told me I was negative. In fact I didn't really believe it until after the seco

            • It's been found through studies of cases like yours that 'vanilla' couples sex, where the partners are otherwise healthy apart from one being HIV+ have well under a percent (.3% IIRC) rate per act of transmitting HIV.
              For anal, this rises to 30%.

              Your numbers are WAY off. The figures are closer to 0.1% and 1% respectively. See this study for details:
              http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1881672/?tool=pmcentrez [nih.gov]

              Other studies have been done for Gay couples and various groups, and the numbers come off simil

    • by TWX (665546) on Wednesday May 16, 2012 @06:10PM (#40022357)
      On the other hand, false positive or real positive, one can possibly seek our medical insurance without having a documented pre-existing condition, and might actually qualify before the expensive regimen of drugs is prescribed to prolong life.
      • Now that is an interesting point.
      • If you RTFA, for every 100 actual cases, it misses 7. That's 7 people who will think that they're HIV-free, and possibly spread it to others.

        7% false negatives is a *terrible* number.

        a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year,

        The test in a clinical setting has a 1% false negative number, and if you're engaged in high-risk behaviour/in

        • by tinkerton (199273)

          I don't know if it will be much lower than 7%. On one end of the spectrum, the test will show a false negative for a reason (a certain stage of the disease, or a variant)and repeating the test will give a failure for the same reason. on the other hand, the failure is random and a repeated test has 0.05% failure. And then the prescribed test procedure would indeed be to repeat it.

        • If you RTFA, for every 100 actual cases, it misses 7. That's 7 people who will think that they're HIV-free, and possibly spread it to others.

          7% false negatives is a *terrible* number.

          No it isn't. If everybody used this test, and the people who tested positive seek treatment, then you just reduced the transmission rate among the people who would not otherwise get tested by 93%.

          I often run in to arguments like this when it comes to vaccinations as well. Many vaccines don't offer perfect protection. They just

          • False dichotomy alert!

            if everybody used this test, and the people who tested positive seek treatment, then you just reduced the transmission rate among the people who would not otherwise get tested by 93%.

            Your argument is based on people either using this test or no test at all. This (inaccurate) test will drive down the number of people who get the more accurate test, resulting in increased numbers of false negatives, which is the real risk.

            The second false dichotomy inherent in your position is that

    • by ClintJCL (264898)
      It must suck to live in a backward world where progress is considered bad.
      • It must suck to live in a backward world where progress is considered bad.

        It must suck to live in a backword mind where the only alternatives are to either let a flawed test go on the market or not , and where improving the tests accuracy is not even considered an option.

        Enjoying your false dichotomy?

        • by ClintJCL (264898)
          Wow. Create a false dichotomy, stick it in my mouth, attack it as a strawman, and call me the one who created it. You are truly fucked. By the FDA's own calculation it will have a net loss of 4,000 infections a year. If you don't like that, maybe you can be one of them and go die.
          • You're the one who considers a 7% false negative rate progress, and says that I must be backward to think otherwise. The false dichotomy (either accept a 7% failure rate or not) is the basis for your attack. Nowhere do you consider that there's a 3rd alternative - make a better test.

            As for "a net loss of 4,000 infections a year" - that's over an order of magnitude worse than current tests. That's 4,000 people (and their partners) who will think they're safe when they're not.

            To quote your own words, bu

            • by ClintJCL (264898)
              ..... net less of new infections. Less new infections. 4,000 fewer new infections. 46,000 new infections next year instead of 50,000. Clearly you did not read the article.

              Now, someone's at a bar on a friday night, and they've decided to hook up. What is your alternative? There is none. So they die instead. I'm talking about when this is released, not a hypothetical future years from now when a better test is released.

              • I read the article. You should read it again.

                a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year

                The FDA estimate of preventing ~4,000 new infections is from the people who got the positive results. However, the number of new infections from the 3,800 who got a false negative and then infect others is left out, and is potentially MUCH greater, nev

                • by ClintJCL (264898)
                  You just equated this as being the same as unprotected sex. Because anyone who gets a negative result would then have unprotected sex? You're thinking just like the fundies! No wonder you have your ridiculous conclusion. (It's also funny that you think they didn't consider your scenario in their numbers.)

                  Uh, no. For any prudent person, A negative result would mean going through with the protected sex would be safer. A positive result would mean it would not be worth even having safe sex. You assume the w

            • by compro01 (777531)

              You're not really going to get a better test short of phlebotomy.

              This exact same test is used clinically today.

              The question they're looking at here is whether to allow it to be bought by anyone in any random drugstore rather than only by doctors/NPs/etc.

              • Or they can do more research to find out why the false negative rate is 7x higher outside of clinics, then eliminate the factors that cause the problems.

                Things like improper storage and handling, not getting a decent sample, etc. We've managed to mitigate most of these issues for other tests, such as blood sugar. For example, (technological improvements) the monitors are now self-calibrating. If you don't get a decently-sized sample, the machine won't give a result rather than give a wrong result. If th

    • The test is 99% reliable when performed correctly. Also, since condoms typically break or slip about 3% of the time, and don't cover the entire penis, the test will be a more effective method of preventing exposure to HIV for many people than a condom.
      • Cut the bs.

        First, the test has been PROVEN to have a false negative rate of 7% outside of clinics. They need to address this issue, identify the causes, and fix them. The FDAs projections are that every year, 3,800 people who use this test and have HIV will wrongly believe that they don't. Want to do a body count projection?

        Second, condoms work [avert.org].

        The male latex condom is the single, most efficient, available technology to reduce the sexual transmission of HIV and other sexually transmitted infections.

    • When you design tests, there are two rules.
      1. You can have a false positive.
      2. You must not have a false negative.

        The reasoning is this: If you have a false positive, you just take another, more expensive, slower test to confirm. If you have a false negative, someone will die.

  • Well this is certainly some...
    *puts on glasses*
    positive news!

    YEEEEEEEEEEEEEEEEEAAH!!
  • And how many milliseconds until this happens:

    A new law was passed today by both houses of Congress making it illegal for pharmacies to sell over the counter HIV tests. The author of the bill, congressman John Q. Religinut, Jr (R) welcomed the passage of the law saying "Today we have taken a stand against promiscuity and the homosexual agenda".

  • What if it was designed so that whether or not you had the HIV virus it showed a positive result? That would be one way to get people to go in for testing.
  • X and Y take the test, and get negatives. X (only) has a false negative. Y blows X and the virus enters through the mouth abrasion caused by the swab.

  • This should be freely available at every counter, station, desk, etc. across which citizens interact with the Federal Government. Because regardless of what your business is, you will always come away having been fucked in the ass.

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